A Pilot Study on the Feasibility of Combined Chemoembolization and Adjuvant Systemic Hyperthermia for Palliative Treatment of Unresectable Hepatocellular Carcinoma(HCC)

Date de début de l'étude : 1 mars 2013

Inclusion Criteria: Patient factor Age between 18 and 75 Child-Pugh A cirrhosis Eastern Cooperative Oncology Group(ECOG) performance status Grade 2 or below No serious concurrent medical illness Prior treatment for HCC including surgery, local ablation, or transarterial treatments allowed Imaging evidence of poor intralesional treatment response or disease progression despite transarterial treatment Platelet count ≥ 50 10^9/L Tumor factor HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology Unresectable and locally advanced disease without extra-hepatic disease Hypervascular lesions on CT Greatest dimension of the largest tumor ≤15cm Exclusion Criteria: Patient factor History of significant concurrent medical illness such as ischemic heart disease or heart failure Metallic body implants, not including dental fillings Serum creatinine level > 130 umol/L Presence of biliary obstruction not amenable to drainage Child-Pugh B or C cirrhosis Unable to give consent Evidence of impaired liver function History of hepatic encephalopathy Intractable ascites not controllable by medical therapy History of variceal bleeding within last 3 months Serum total bilirubin level >25 umol/L for the first 5 patients, serum total bilirubin level >35 umol/L for the second 5 patients Serum albumin level < 30g/L International normalized ratio(INR) >1.3 Tumor factor Presence of extrahepatic metastasis Infiltrative lesion Vascular invasion Hepatic artery thrombosis Partial or complete thrombosis of the main portal vein Tumor invasion of portal branch of contralateral lobe Hepatic vein tumor thrombus Significant arterioportal shunt Significant arteriovenous shunt Contraindication for hyperthermia Known brain metastasis Recent stroke or cerebral hemorrhage within last 6 months Poorly controlled epilepsy Poorly controlled cardiac arrhythmias Myocardial infarction within last 6 months Unstable angina within last 6 months Poorly controlled hypertension Poorly controlled diabetes History of malignant hyperthermia Photodermatosis Pregnancy Lactation Serious infection Grade 3 or above adverse event in serological total bilirubin or albumin according to Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events Elevation of serum alanine transaminase ≥ 10 times upper limit of normal